Matthias Rath, who advocates the use of vitamins and nutrition to treat HIV/AIDS, on Tuesday placed a full-page advertisement in the New York Times and the International Herald Tribune claiming antiretroviral drugs are toxic, Reutersreports. Rath accuses the United States, the United Kingdom, the World Bank and the United Nations of only advocating for the use of antiretrovirals to support the multinational pharmaceutical industry, according to Reuters. Rath in his ads says that micronutrients are "an effective, safe and affordable" means to combat HIV/AIDS, according to Reuters (Bell, Reuters, 5/10). Rath's ads say that his claims are supported by a study by researchers from Harvard UniversitySchool of Public Health that was published in July 2004 in the New England Journal of Medicine, according to South Africa's Business Day (Kahn, Business Day, 5/11).

Harvard Study
Researchers from Harvard and Muhimbili University College of Health Sciences in Tanzania between 1995 and 2003 studied 1,078 pregnant HIV-positive women in Dar es Salaam, Tanzania, who did not have access to antiretroviral treatment. Researchers randomly assigned participants to receive a multivitamin, a multivitamin with vitamin A, vitamin A alone or a placebo. The multivitamins contained about three times the recommended daily allowance of vitamin E and six to 10 times the allowance of vitamins C and B-complex. Participants in the study, which was funded by the National Institute of Child Health and Human Development, took the vitamins during pregnancy and for the duration of the study. All of the participants received folic acid and an iron supplement during pregnancy, regardless of whether they received placebos or vitamins. Participants received periodic checkups for four years after delivering their infants, and about half of the participants received checkups for more than five years after delivering. Researchers monitored participants to determine if the supplements affected the progression of HIV to severe symptoms, AIDS or death. Researchers also examined the effect of the supplements on the patients' immune systems and viral loads. The findings show that the benefits of multivitamins were statistically significant, however, the results were not dramatic. Researchers found that 67 of the 271 participants who received multivitamins progressed to an advanced stage of disease or they died, compared with 83 of the 267 women in the placebo group (Kaiser Daily HIV/AIDS Report, 7/1/04).

Harvard Response
The Harvard researchers -- Wafaie Fawzi and David Hunter -- in a statement said that Rath in the ads is "deliberately misinterpreting" their findings to support his "campaign against antiretrovirals," according to SAPA/Mail & Guardian. "We condemn these irresponsible and misleading statements (by Rath) as in our view they deliberately misinterpret findings from our studies to advocate against the scale up of antiretroviral therapy," the researchers said, adding, "[I]t is important to underscore that the multivitamin supplements should not be considered as an alternative to [antiretroviral therapy] but as a complementary intervention that is part of a comprehensive care package. Antiretroviral therapy saves lives, and its scale up should be vigorously pursued in all countries" (SAPA/Mail & Guardian, 5/10).

WHO, UNICEF, UNAIDS Joint Statement
The World Health Organization, UNICEF and UNAIDS on Wednesday released a joint statement saying that Rath's claims about antiretroviral drugs being toxic are "misleading and potentially dangerous," according to Agence France-Presse. "These advertisements, placed in the international press, are wrong and misleading," the statement said, adding, "Misrepresentations of this sort are both dangerous and unhelpful." The statement said that the agencies are "extremely concerned" that Rath had taken their past statements about the importance of a "sound diet" for HIV/AIDS patients "out of context" and used them to support his claims, according to Agence France-Presse. The agencies said that although vitamins and minerals are important for HIV/AIDS patients, they cannot substitute for a balanced diet and treatment, according to Agence France-Presse. "In countries where it is widely available, antiretroviral therapy has turned AIDS from a 'death sentence' into a chronic but manageable disease," the statement said, adding, "As with any other drugs, antiretroviral treatments do have side effects that have been documented in clinical trials" (Agence France-Presse, 5/11).

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MCC Investigation
The South African Medicines Control Council and the Department of Health on Wednesday confirmed that they are investigating the Dr. Rath Health Foundation, according to the SAPA/News24.com. "The investigation has not yet been completed," the agencies said in a joint statement, adding, "Therefore (we) are not at liberty to discuss the merits and demerits of the investigation, as doing so would jeopardize both the investigation and proposed interventions." The agencies said that the investigation began in April and is being led by Humphrey Zokufa, the registrar of medicines, who is being assisted by Joey Gouws, head of the law enforcement directorate in the Department of Health (SAPA/News24.com, 5/11).

Lawsuit
The South African HIV/AIDS treatment advocacy group Treatment Action Campaign has asked the Cape High Court to issue a temporary injunction to prevent the Rath Foundation and Rath from making defamatory statements about the organization. In some of its ads, the Rath Foundation suggests that TAC and other groups are front organizations for the pharmaceutical industry and that the group has misled people to believe that "exorbitantly expensive and highly toxic drugs like AZT and nevirapine" can successfully treat HIV infection. TAC has encouraged the South African government to provide access to antiretroviral drugs for HIV-positive people in the country. Rath and his foundation have filed a response to TAC's request, saying that the foundation's claims about antiretrovirals are true and their criticism of TAC is allowed under the constitutional right to free expression (Kaiser Daily HIV/AIDS Report, 4/15). The case is scheduled to be heard by the Cape High Court on Friday. TAC has said that it will extend its legal action to cover the new ads, according to Reuters. "We have received legal advice that we should include the defamation outside of South Africa's borders and seek to stop the campaign in foreign newspapers in the same way as we are seeking to stop it (here)," TAC Treasurer Mark Heywood said (Reuters, 5/10).

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